BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY 7FR. 40CC IAB - JAPAN

    MDR report key: 6756417 · Received August 1, 2017

    Report

    Report Number
    2248146-2017-00190
    Event Type
    Malfunction
    Date Received
    August 1, 2017
    Date of Event
    July 4, 2017
    Report Date
    August 18, 2017
    Manufacturer
    DATASCOPE FAIRFIELD
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    08/18/2017 (B)(4):THE IAB CATHETER WAS RETURNED WITH THE MEMBRANE COMPLETELY UNFOLDED AND BLOOD ON THE EXTERIOR OF THE CATHETER. THE SHEATH WAS NOT RETURNED FOR EVALUATION. NO BLOOD WAS OBSERVED INSIDE THE IAB CATHETER. ONE KINK WAS FOUND ON THE CATHETER TUBING NEAR THE Y-FITTING APPROXIMATELY 75.9CM FROM THE IAB TIP. MULTIPLE ATTEMPTS TO OBTAIN CLARIFICATION OF THE REPORTED EVENT WERE UNSUCCESSFUL. SINCE IT WAS REPORTED THERE WAS NO PATIENT INJURY AS WELL AS "BLEEDING" AT THE SHEATH INSERTION, THE INVESTIGATION FOCUSED ON A BLOOD LEAK IN THE SHEATH WHERE THE IAB IS INSERTED. THE RETURNED IAB CATHETER WAS LEAK TESTED AND NO LEAKS WERE FOUND. THE SHEATH WAS NOT RETURNED, SO WAS NOT ABLE TO BE TESTED, MAKING THE EVALUATION UNABLE TO DUPLICATE THE REPORTED PROBLEM. A DEVICE AND LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NON-CONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. COMPLAINT # (B)(4); RECORD # 142319.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER, BUT IS PENDING INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A SUPPLEMENTAL REPORT WITH OUR FINDINGS WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY AN IAB WAS INSERTED IN THE FEMORAL ARTERY WITH AMI PATIENT USING SHEATH AND STARTED PUMPING. BLEEDING FROM SHEATH INSERTION WAS NOTED DURING IAB THERAPY. THE IAB WAS REMOVED AND A NEW IAB WAS INSERTED INTO OPPOSITE ARTERY TO CONTINUE THERAPY. THERE WAS NO PATIENT INJURY OR HARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) CATHETER THERAPY AN IAB WAS INSERTED IN THE FEMORAL ARTERY WITH AMI PATIENT USING SHEATH AND STARTED PUMPING. BLEEDING FROM SHEATH INSERTION WAS NOTED DURING IAB THERAPY. THE IAB WAS REMOVED AND A NEW IAB WAS INSERTED INTO OPPOSITE ARTERY TO CONTINUE THERAPY. THERE WAS NO PATIENT INJURY OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539228 TRANS-RAY 7FR. 40CC IAB - JAPAN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE FAIRFIELD 3000030698

    Patients

    Seq Age Sex Outcome Treatment
    1